A TISSUE OXYGEN MONITOR

研究计划是继续开发和评估一种微型、机械坚固、简单、廉价、微创的电化学氧传感器。它用于在重建手术后插入皮瓣或游离肌肉移植，并将监测氧气长达五天。外护套控制传感器的操作环境，并且膜排除会污染电极的大分子。测量周期旨在避免较小物种的干扰。将对预期影响器械准确性或稳定性的尺寸和工艺进行系统评价，并确定最终工艺和材料质量标准及公差。将设计和建造特殊的工具和设备，以提高再现性并降低制造成本。将开发筛选方法，以剔除有缺陷的组件，并提供有关流程的反馈，以提高产量。将在实验室中对器械的准确性、稳定性和响应时间进行广泛测试。评价方案将包括灭菌和储存。将在主动操纵血供的兔组织瓣中评价短期性能。将在带皮瓣或游离组织移植的家兔中评价长期稳定性。所有动物研究将包括在完整或受干扰较少的组织中的第二个传感器。将指示氧水平与静脉氧水平、灌注不良的临床指征和转移坏死程度进行比较。将检查长期使用动物的组织是否对器械产生不良异物反应。拟议的商业应用：该器械将用于在重建手术期间移植后直接监测组织氧合，并提供血管凝血的早期预警。它解决了现有器械的局限性，并提供了目前不可用的临床相关数据。预计它将占据美国市场的很大一部分，估计为8，000，000美元。

The research plan is for the continued development and evaluation of a miniature, mechanically rugged, simple, inexpensive, minimally invasive, electrochemical oxygen sensor. It is intended for insertion in flap or free muscle transplants after reconstructive surgery and will monitor oxygen for up to five days. An outer sheath controls the operating environment of the sensor and a membrane excludes large molecules that would contaminate the electrodes. The measurement cycle is designed to avoid interference from smaller species. Dimensions and processes expected to affect the accuracy or stability of the device will be systematically evaluated and final process and material specifications and tolerances established. Special tooling and equipment will be designed and built to improve reproducibility and reduce fabrication costs. Screening methods will be developed to reject defective components and to provide feedback on processes for improved yields. Devices will be tested extensively in the laboratory for accuracy, stability, and response time. Evaluation protocols will include sterilization and storage. Short term performance will be evaluated in rabbit tissue flaps with active manipulation of blood supply. Long term stability will be evaluated in rabbits with flaps or free tissue transfers. All animal studies will include a second sensor in intact or less disturbed tissue. Indicated oxygen level will be compared with venous oxygen levels, clinical indications of poor perfusion, and degree of transfer necrosis. Tissue from the long term animals will examined for adverse foreign body reactions to the device. PROPOSED COMMERCIAL APPLICATIONS: The device will be used to permit direct monitoring of tissue oxygenation after grafting during reconstructive surgery and provide early warning of clotting of blood vessels. It addresses limitations of existing devices and provides clinically relevant data not presently available. It is expected to capture a significant portion of a market estimated at $8,000,000 in the US.